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Pyridostigmine Bromide 180 mg Tablet, 30-count

by Rising Pharma Holdings, Inc. · 30 TABLET in 1 BOTTLE (64980-220-03)
NDC 64980-0220-03
🏷️ FDA NDC (as labeled) 64980-220-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 64980-220-03
Product NDC 64980-220
11-digit billing NDC 64980022003
NCPDP billing unit EA — each (per item)
RxCUI 903847
UNII KVI301NA53
UPC 0364980220033
Application # ANDA205464
SPL Set ID f7a75639-a23a-4847-a962-c091c61947f0
Established class (EPC) Cholinesterase Inhibitor
Mechanism of action Cholinesterase Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-08-15
Route ORAL
Dosage form TABLET
Substance PYRIDOSTIGMINE BROMIDE
GPI-14 76000050100405
GPI class Pyridostigmine Bromide ER
GCN Seq No 004765
GCN 18540
HICL code 001990
Ingredient (HICL) Pyridostigmine Bromide
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J1
Therapeutic class — intermediate (HIC2) Cholinergics
HIC3 code J1B
Therapeutic class — specific (HIC3) Cholinesterase Inhibitors
AHFS code 12:04.00.00
AHFS class Parasympathomimetic (Cholinergic Agents)
FDB label name PYRIDOSTIGMINE ER 180 MG TAB
FDB brand name Pyridostigmine Bromide Er
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 64980-220-03 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 64980-0220-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Anticholinesterases
How it works Cholinesterase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerRising Pharma Holdings, Inc.
Application holderRISING PHARMA HOLDINGS INC
FDA applicationANDA205464 (ANDA)
Labeler code64980
First marketedAug 2017
Product typeHuman Prescription Drug
Portfolio525 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PYRIDOSTIGMINE ER 180 MG TAB Ingredient Pyridostigmine Bromide
📗 Our plain-language guide HelloPharmacist
  • Think of it as a protective shield you put up before a threat arrives. Pyridostigmine temporarily occupies key spots on an enzyme in your body that soman would otherwise permanentl...
  • What exactly is pyridostigmine supposed to do for me — does it actually stop soman from hurting me?
  • Timing is everything with this medication. It needs to be started at least several hours before any anticipated exposure — not when an alarm goes off. If you take it immediately be...
  • Does it matter when I take it? Can I just take it right before a threat?
📖 Read our full Pyridostigmine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 91D9GV0Z28
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
  • UNII 80N308T1NN
    Zein is a natural protein extracted from corn. It's used as a film-coating agent and binder in tablets and capsules to improve appearance, protect the medicine, and help it dissolve properly.

5 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $4.294 $128.83 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $5.08 $152.51 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $6.20 $186.11 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Jul 2022 Dec 2025 Aug 2026 $6.311 $3.789
▼ Down 26% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
pyridostigmine bromide 180 mg 68682-0301-30 Oceanside 30 tablets $3.789 AB FDA listed save 12%
Pyridostigmine Bromide 180 mg 47781-0335-30 Alvogen, 30 tablets $4.294 AB Availability likely —
Pyridostigmine Bromide 180 mgthis 64980-0220-03 Rising 30 tablets $4.294 AB Availability likely —
Mestinon 180 mg 00187-3013-30 Bausch 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 64980-0220-03, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
66.2K
Gross reimbursed last 4 qtrs
$336.3K
Avg / prescription
$294.23
Avg / unit
$5.0836
Latest quarter Q4 2025
212Rx
Medicaid pays / ea
$5.0836
gross reimbursed
vs
NADAC / ea
$4.2944
acquisition cost
=
Spread
+$0.7892
+18% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 479 Rx Managed care · 664 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 510 units · 6.5 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 2,100 units · 35.5 per 100k residents WI Michigan: 990 units · 9.9 per 100k residents MI New York: 12,055 units · 61.6 per 100k residents NY Vermont: no data reported VT New Hampshire: 690 units · 49.2 per 100k residents NH Oregon: 450 units · 10.6 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 1,500 units · 12.0 per 100k residents IL Indiana: 1,500 units · 21.9 per 100k residents IN Ohio: 4,022 units · 34.1 per 100k residents OH Pennsylvania: 4,745 units · 36.6 per 100k residents PA New Jersey: 1,740 units · 18.7 per 100k residents NJ Massachusetts: no data reported MA California: 17,821 units · 45.7 per 100k residents CA Utah: 1,540 units · 45.1 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: 2,355 units · 52.0 per 100k residents KY West Virginia: 1,020 units · 57.6 per 100k residents WV Virginia: no data reported VA Maryland: 4,830 units · 78.2 per 100k residents MD Connecticut: 900 units · 24.9 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 1,330 units · 12.3 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 360 units · 7.9 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,218 units · 7.3 per 100k residents TX Florida: 1,438 units · 6.4 per 100k residents FL
Units reimbursed · per 100k residents
6.478.2
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Maryland 78.2 /100k
2 New York 61.6 /100k
3 West Virginia 57.6 /100k
4 Kentucky 52.0 /100k
5 New Hampshire 49.2 /100k
6 California 45.7 /100k
7 Utah 45.1 /100k
8 Pennsylvania 36.6 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pyridostigmine Bromide — the program that covers self-administered drugs. 9 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pyridostigmine Bromide. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$5.53M
Claims incl. refills
71.4K
Beneficiaries
45.1K
Spend / beneficiary
$122.42
Spend / claim
$77.39
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PYRIDOSTIGMINE BROMIDE — the ingredient across all brands.

Top reported reactions

Myasthenia Gravis1,221
Fatigue915
Asthenia742
Diarrhoea681
Dyspnoea633
Headache620
Nausea587

Age at onset

Neonate14
Infant8
Child20
Adolescent21
Adult736
Elderly718

Reporter sex

10,644 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization3,762
Death806
Life-threatening611
Disabling242
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 781 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
64980-0220-03 You're viewing this 30 TABLET in 1 BOTTLE (64980-220-03) 2017-08-15 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📋 Description
⏱️ Dosage and Administration 191 words ▾

DOSAGE AND ADMINISTRATION Pyridostigmine bromide is available in one dosage form. Extended-release Tablets - each containing 180 mg Pyridostigmine bromide. This form provides uniformly slow release, hence prolonged duration of drug action; it facilitates control of myasthenic symptoms with fewer individual doses daily.

The immediate effect of a 180 mg Extended-release Tablet is about equal to that of a 60 mg Conventional Tablet, however, its duration of effectiveness, although varying in individual patients, averages 2 ½ times that of a 60 mg dose. Dosage The size and frequency of the dosage must be adjusted to the needs of the individual patient. Extended-release Tablets - One to three 180 mg tablets, once or twice daily, will usually be sufficient to control symptoms; however, the needs of certain individuals may vary markedly from this average.

The interval between doses should be at least 6 hours. For optimum control, it may be necessary to use the more rapidly acting regular tablets or syrup in conjunction with extended-release therapy. Note: For information on a diagnostic test for myasthenia gravis, and for the evaluation and stabilization of therapy, please see product literature on Tensilon® (edrophonium chloride).

⛔ Contraindications 41 words ▾

CONTRAINDICATIONS Pyridostigmine bromide is contraindicated in mechanical intestinal or urinary obstruction, and particular caution should be used in its administration to patients with bronchial asthma. Care should be observed in the use of atropine for counteracting side effects, as discussed below.

⚠️ Warnings ~1 min read ▾

WARNINGS Although failure of patients to show clinical improvement may reflect underdosage, it can also be indicative of overdosage. As is true of all cholinergic drugs, overdosage of Pyridostigmine bromide may result in cholinergic crisis, a state characterized by increasing muscle weakness which, through involvement of the muscles of respiration, may lead to death. Myasthenic crisis due to an increase in the severity of the disease is also accompanied by extreme muscle weakness, and thus may be difficult to distinguish from cholinergic crisis on a symptomatic basis.

Such differentiation is extremely important, since increases in doses of Pyridostigmine bromide or other drugs of this class in the presence of cholinergic crisis or of a refractory or "insensitive" state could have grave consequences. Osserman and Genkins 1 indicate that the differential diagnosis of the two types of crisis may require the use of Tensilon® (edrophonium chloride) as well as clinical judgment. The treatment of the two conditions obviously differs radically.

Whereas the presence of myasthenic crisis suggests the need for more intensive anticholinesterase therapy, the diagnosis of cholinergic crisis, according to Osserman and Genkins 1 calls for the prompt withdrawal of all drugs of this type. The immediate use of atropine in cholinergic crisis is also recommended. Atropine may also be used to abolish or obtund gastrointestinal side effects or other muscarinic reactions; but such use, by masking signs of overdosage, can lead to inadvertent induction of cholinergic crisis.

For detailed information on the management of patients with myasthenia gravis, the physician is referred to one of the excellent reviews such as those by Osserman and Genkins 2 , Grob 3 or Schwab. 4, 5 Usage in pregnancy: The safety of Pyridostigmine bromide during pregnancy or lactation in humans has not been established. Therefore, use of Pyridostigmine bromide in women who may become pregnant requires weighing the drug's potential benefits against its possible hazards to mother and child.

🤒 Adverse Reactions 125 words ▾

ADVERSE REACTIONS The side effects of Pyridostigmine bromide are most commonly related to overdosage and generally are of two varieties, muscarinic and nicotinic. Among those in the former group are nausea, vomiting, diarrhea, abdominal cramps, increased peristalsis, increased salivation, increased bronchial secretions, miosis and diaphoresis. Nicotinic side effects are comprised chiefly of muscle cramps, fasciculation and weakness.

Muscarinic side effects can usually be counteracted by atropine, but for reasons shown in the preceding section the expedient is not without danger. As with any compound containing the bromide radical, a skin rash may be seen in an occasional patient. Such reactions usually subside promptly upon discontinuance of the medication.

To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

📦 How Supplied / Storage and Handling 89 words ▾

HOW SUPPLIED Extended-release Tablets are available as light straw colored capsule-shaped tablets containing 180 mg Pyridostigmine bromide in bottles of 30 (NDC 64980-220-03). Each tablet is engraved "NM 180" on one side and is single-scored on the other. Note : Because of the hygroscopic nature of the Extended-release Tablets, mottling may occur.

This does not affect their efficacy. Store Pyridostigmine Bromide Extended-Release Tablets, 180 mg at 25°C (77°F), excursions permitted to 15°C-30°C (59°F-86°F). Keep Pyridostigmine Bromide Extended-Release Tablets, 180 mg in a dry place with the silica gel enclosed.

📋 Description 119 words ▾

DESCRIPTION Pyridostigmine bromide is an orally active cholinesterase inhibitor. Chemically, Pyridostigmine bromide is 3-hydroxy-1-methylpyridinium bromide dimethylcarbamate. Its structural formula is: Pyridostigmine bromide is available in the following form: Extended-release tablets containing 180 mg Pyridostigmine bromide, each tablet also contains colloidal silicon dioxide, carnauba wax, tribasic calcium phosphate, zein (corn protein) and magnesium stearate.

ACTIONS Pyridostigmine bromide inhibits the destruction of acetylcholine by cholinesterase and thereby permits freer transmission of nerve impulses across the neuromuscular junction. Pyridostigmine is an analog of neostigmine (Prostigmin®), but differs from it in certain clinically significant respects, for example, Pyridostigmine is characterized by a longer duration of action and fewer gastrointestinal side effects. INDICATION Pyridostigmine bromide is useful in the treatment of myasthenia gravis. pyridostigmine-structre.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 64980-0211-01 · Rising 64980-0221-01 · Rising →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.